510(k) K051816 ยท ILY Lamp, Infrared, Therapeutic Heating
LUMIWAVE 1X4 INFRARED THERAPY DEVICE
| Applicant | Biocare Systems, Inc., Denver CO, US |
| Decision | Substantially Equivalent, Aug 26, 2005 |
| Received | Jul 5, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051816
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2006 | Biocare Systems Inc. LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc. Terminated |
ILY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.